Trial Outcomes & Findings for Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim (NCT NCT03440047)
NCT ID: NCT03440047
Last Updated: 2023-10-03
Results Overview
Subjects presenting with gastrointestinal mucosal disorders will have a biopsy based on clinical standard of care. Just prior to the biopsy, a standard set of electronic images will be captured using the Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology. Images will be correlated with the final clinical and histological diagnosis of the gastrointestinal disorder.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
355 participants
Primary outcome timeframe
Approximately one year
Results posted on
2023-10-03
Participant Flow
Participant milestones
| Measure |
Fuji Film Processor VP-7000
Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
|
|---|---|
|
Overall Study
STARTED
|
355
|
|
Overall Study
COMPLETED
|
353
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Fuji Film Processor VP-7000
Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Baseline characteristics by cohort
| Measure |
Fuji Film Processor VP-7000
n=355 Participants
Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
|
|---|---|
|
Age, Continuous
|
59.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
336 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
325 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
355 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately one yearPopulation: Participants with available histopathological \[or other clinical results\] to correlate with the images collected endoscopically
Subjects presenting with gastrointestinal mucosal disorders will have a biopsy based on clinical standard of care. Just prior to the biopsy, a standard set of electronic images will be captured using the Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology. Images will be correlated with the final clinical and histological diagnosis of the gastrointestinal disorder.
Outcome measures
| Measure |
Fuji Film Processor VP-7000
n=320 Participants
Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
|
|---|---|
|
Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis
|
283 participants
|
Adverse Events
Fuji Film Processor VP-7000
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fuji Film Processor VP-7000
n=355 participants at risk
Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Vascular disorders
Stroke
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Gastrointestinal disorders
Esophageal Perforation
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Gastrointestinal disorders
Gastric ulcers
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Gastrointestinal disorders
Hematemesis
|
0.28%
1/355 • Number of events 2 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
Other adverse events
| Measure |
Fuji Film Processor VP-7000
n=355 participants at risk
Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
|
|---|---|
|
Surgical and medical procedures
Tooth extraction
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Gastrointestinal disorders
Perirectal abscess
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Vascular disorders
Vasculitis
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Injury, poisoning and procedural complications
Fall secondary to syncope
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Injury, poisoning and procedural complications
Opioid overdose
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Endocrine disorders
Hyperglycemia
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Infections and infestations
Clostridium difficile
|
0.28%
1/355 • Number of events 1 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Infections and infestations
COVID-19
|
0.56%
2/355 • Number of events 2 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
|
Gastrointestinal disorders
Vomiting
|
0.56%
2/355 • Number of events 2 • Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place